Comparative study of the equivalence of the biosimilar follitropin alpha preparation (solution for subcutaneous injection) and the original follitropin alpha preparation (lyophilisate for preparation of solution for subcutaneous administration) in women with different responses to ovarian stimulation in an in vitro fertilization program: results of a phase IV clinical trial


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Abstract

The efficacy and safety of any medication should be proven in randomized prospective clinical trials. However, the data obtained in real clinical practice are important for the formation of the evidence base and make the results of the study on the effectiveness and safety of the medications available to a wide population of patients. Objective: To determine the equivalence of the biosimilar follitropin alpha preparation (Primapur, solution for subcutaneous administration) and the original follitropin alpha preparation (Gonal-F, lyophilisate for preparation of solution for subcutaneous administration) in women with different responses to ovarian stimulation in an in vitro fertilization program. Materials and methods: This is a retrospective, non-interventional (observational), cohort, comparative, multicenter study of the efficacy and safety of the biosimilar follitropin alpha preparation (Primapur, solution for subcutaneous administration, IVFarma, Russia), and the original follitropin alpha preparation (Gonal-F, lyophilisate for preparation of solution for subcutaneous administration, Merck-Serono, Italy). A total of 240 patients were included in the study: 120 patients received Primapur, a solution for subcutaneous administration, and 120 patients used Gonal-F, lyophilisate for preparation of solution for subcutaneous administration. The patients were stratified depending on the parameters of the ovarian reserve and the expected ovarian response. Results: The results of the study confirmed the therapeutic equivalence of the biosimilar follitropin alpha preparation (Primapur, solution for subcutaneous administration) and the original follitropin alpha preparation (Gonal-F, lyophilisate for preparation of solution for subcutaneous administration) in women with different responses to ovarian stimulation in an in vitro fertilization program. There were no statistical differences in the parameters of the stimulated cycle: in the initial, daily and total dose of drugs, in the number of aspirated and mature oocytes, zygotes, blastocysts, blastocysts of good quality and cryopreserved embryos in the compared groups. The outcomes of in vitro fertilization programs (the rate of biochemical pregnancy, clinical pregnancy, early reproductive losses and ongoing pregnancy) were also comparable in the subgroups with hypo-response, normal response and hyper-response and did not differ statistically. Conclusion: The biosimilar follitropin alfa preparation (Primapur, solution for subcutaneous injection) can be recommended for a wide use in clinical practice in various categories of patients in the in vitro fertilization programs, regardless of the parameters of the ovarian reserve and the type of ovarian response.

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About the authors

Svetlana G. Perminova

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Dr. Med. Sci., Leading Researcher at Reproductology Department

Tatiana A. Nazarenko

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: t_nazarenko@oparina4.ru
Dr. Med. Sci., Professor, Director of the Institute of Reproductive Medicine

Irina E. Korneeva

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: irina.korneeva@inbox.ru
Dr. Med. Sci., Professor, Senior Researcher at the Scientific and Clinical Department of Assisted Reproductive Technology named after F. Paulsen

Nadezda V. Bashmakova

Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia

Dr. Med. Sci., Professor, Honored Doctor of the Russian Federation, Head of the Department of ART, Chief obstetrician-gynecologist of the Ural Federal District, Chief Researcher

Elena V. Mityurina

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: e_mityurina@oparina4.ru
PhD, Senior Researcher at Reproductology Department

Olga A. Alimova

Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia

PhD, Reproductologist at the Department of Assisted Reproductive Technologies

Irina S. Belova

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: irina-belova00@mail.ru
graduate student

Andrey V. Ershov

Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia

Junior Researcher at the Department of Assisted Reproductive Technologies

Alexandra Yu. Khramtsova

Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia

Email: aleksaxr@mail.ru
obstetrician-gynecologist, researcher, Department of ART

El’mira R. Dzhalilova

Urals Research Institute of Maternity and Child Care, Ministry of Health of Russia

Email: vip.dzhalilova20l7@mail.ru
obstetrician-gynecologist at the Department of Assisted Reproductive Technologies

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